MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW 7 XB BISECTOR (US); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VASOVIEW 7 XB BISECTOR (US)
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview 7 xb bisector blue button of bisector device was sliding in a faulty manner.It actually would not move on the bisector so they could not open or close the bisector jaws.A new vh-3200 was opened to finish the procedure.No harm to patient.
Additional Manufacturer Narrative
Trackwise id (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise # (b)(4).Updated sections: b4, d10, g4, g7, h2, h3, h6, h10.Analysis of production: (3331/213/67) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period (b)(6) 2020 through (b)(6) 2022 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device: (10/13/22) the device was returned to the factory for evaluation on (b)(6) 2022.An investigation was conducted on (b)(6) 2022.A visual inspection was conducted.Signs of clinical use and slight evidence of tissue was observed on the bipolar blades.A mechanical evaluation was conducted.The blue toggle was manipulated to extend and retract the cutter blade.The toggle would not move and the cutter blade wouldn't retract or extend.The cutter blade was observed to stuck in between the bipolar blades at the base of the jaws.No other visual defects were observed.Based on the returned condition of the device and the results of the investigation, the reported failure "mechanical problem" was confirmed.

• Brand Name: VASOVIEW 7 XB BISECTOR (US)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 13524613
• Report Number: 2242352-2022-00138
• Device Sequence Number: 20161631
• Product Code: GEI
• UDI-Device Identifier: 00607567700369
• UDI-Public: 00607567700369
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2023
• Device Model Number: VASOVIEW 7 XB BISECTOR (US)
• Device Catalogue Number: VH-3200
• Device Lot Number: 25160399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 118 KG